MITRACLIP SGC0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648195921), received between Sep 12, 2016 and Aug 24, 2017 — classified as 1 death, 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method

  THIS IS FILED TO REPORT THE USE OF AN EXPIRED DEVICE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT GRADE 4 DEGENERATIVE MITRAL REGURGITATION. ONE CLIP WAS SUCCESSFULLY IMPLANTED REDUCING MR TO GRADE 1. POST PROCEDURE, IT WAS NOTICED THAT THE STEERABLE GUIDE CATHETER (SGC) EXPIRED SIX DAYS PRIOR TO THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6818589 ↗
• MalfunctionJul 12, 2017Break

  THIS IS FILED TO REPORT THE STEERABLE GUIDE CATHETER (SGC) CABLE BREAK. IT WAS REPORTED THAT AFTER THE SGC WAS PREPARED FOR USE, IT WAS BACKLOADED ON THE GUIDE WIRE, BUT WHEN THE MINUS KNOB WAS TURNED, THE CABLE BROKE. A NEW SGC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709035 ↗
• InjuryApr 7, 2017Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS FILED FOR THROMBUS OBSERVED DURING USE WITH THE STEERABLE GUIDE CATHETER (SGC). IT WAS REPORTED THAT THE PATIENT, WITH DEGENERATIVE MITRAL REGURGITATION, UNDERWENT A MITRACLIP PROCEDURE. THE SGC WAS INSERTED, AND THE FIRST CDS (60808U129) WAS ADVANCED INTO THE PATIENT ANATOMY WITHOUT DIFFICULTY; HOWEVER, A CABLE BREAK OCCURRED. THE CDS WAS REMOVED AND REPLACED. A SECOND CDS WAS ADVANCED INTO THE ANATOMY AND THE CLIP WAS DEPLOYED, REDUCING THE MR FROM 4 TO 2. A THIRD CDS (60808U126) WAS ADVANCED INTO THE LEFT VENTRICLE; HOWEVER, THROMBUS WAS NOTED IN THE RIGHT ATRIUM AND THE PROCEDURE WAS STOPPED. THE ACTIVATED CLOTTING TIME (ACT) WAS AT 300. NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE THROMBUS. THE PROCEDURE ENDED WITH THE MR AT GRADE 2. POST PROCEDURE, THE PATIENT IS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 6473039 ↗
• InjuryFeb 13, 2017Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT THE CLOT THAT WAS OBSERVED. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. TWO CLIPS ((B)(4)) WERE IMPLANTED, REDUCING THE MR TO <1. ON (B)(6) 2017, THE PATIENT PRESENTED WITH DYSPNEA AND IT WAS FOUND THAT ONE CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE MR HAD INCREASED TO 4+. ON (B)(6) 2017, A SECOND MITRACLIP PROCEDURE WAS PERFORMED IN ATTEMPT TO STABILIZE THE SLDA CLIP AND REDUCE THE MR. THE STEERABLE GUIDING CATHETER (SGC) WAS ADVANCED TO THE LEFT ATRIUM; HOWEVER, A CLOT WAS OBSERVED ON THE RIGHT SIDE OF THE HEART. THE SGC WAS REMOVED AND THE CLOT WAS ASPIRATED. THE PROCEDURE WAS DISCONTINUED, AND THE PATIENT WILL BE BROUGHT BACK AT A LATER DATE FOR A NEW PROCEDURE. THE PATIENT IS CURRENTLY STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 6327723 ↗
• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT THE THROMBUS, REQUIRING INTERVENTION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND 8,000U OF HEPARIN WAS ADMINISTERED. THE ACTIVATED CLOTTING TIME (ACT) WAS 266 SECONDS. AN ADDITIONAL 2,000U OF HEPARIN WAS ADMINISTERED. THE STEERABLE GUIDING CATHETER (SGC) WAS ADVANCED AND THEN THE CLIP DELIVERY SYSTEM (CDS). WHILE ATTEMPTING TO STRADDLE THE DEVICES, A LARGE THROMBUS WAS SEEN ON THE RIGHT ATRIAL WALL. AN ADDITIONAL 3,000U OF HEPARIN WAS ADMINISTERED. THE DECISION WAS MADE TO CONTINUE TO WATCH THE THROMBUS. THE CDS WAS THEN ADVANCED TO THE MITRAL VALVE, BUT THE THROMBUS WAS THEN NOTED ON THE CLIP. THE CDS WAS REMOVED WITH THE THROMBUS CLOT AND A CT SCAN WAS PERFORMED, WHICH CONFIRMED THAT THE THROMBUS WAS REMOVED FROM THE PATIENT ANATOMY. NO ADDITIONAL THROMBUS WAS SEEN IN THE PATIENT AND THE PATIENT REMAINED STABLE. THE PROCEDURE WAS STOPPED WITH NO CLIPS IMPLANTED. THE PATIENT MAY BE BROUGHT BACK AT A LATER TIME FOR A NEW MITRACLIP PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 6305920 ↗
• InjuryJan 24, 2017Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS FILED FOR THE PERICARDIAL EFFUSION. IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT, WITH DEGENERATIVE MITRAL REGURGITATION, UNDERWENT A MITRACLIP PROCEDURE. THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED WITHOUT DIFFICULTY INTO THE LEFT ATRIUM. THE FIRST CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED AND THE CLIP DEPLOYED WITHOUT ISSUE. A SECOND CDS WAS ADVANCED; HOWEVER, A PERICARDIAL EFFUSION WAS NOTED AND THE CDS WAS REMOVED WITHOUT DEPLOYMENT OF THE SECOND CLIP. THE SGC WAS REMOVED WITHOUT DIFFICULTY AND THE EFFUSION STOPPED. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE EFFUSION. THE CAUSE OF THE PERICARDIAL EFFUSION WAS UNKNOWN, BUT THE PHYSICIAN REPORTED THAT AFTER THE FIRST CDS WAS REMOVED, THE SGC WAS PULLED BACK TO THE SEPTUM AND THEN RE-ADVANCED WHEN THE SECOND CDS WAS INSERTED. IT WAS THOUGHT THAT POSSIBLY, WHEN THE SGC WAS PULLED BACK, IT WAS PULLED BACK ACROSS THE SEPTUM INTO THE RIGHT ATRIUM. WHEN THE SGC WAS RE-ADVANCED INTO POSITION IN THE LEFT ATRIUM, IT ENTERED A FLAP IN THE SEPTUM, CAUSING THE PERICARDIAL EFFUSION. THERE WAS NO FLAP NOTED PRIOR TO, DURING OR AFTER THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE SEPTUM AFTER THE SGC WAS REMOVED. OTHER T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6274859 ↗
• InjuryJan 20, 2017Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT THAT AFTER THE STEERABLE GUIDING CATHETER (SGC) WAS REMOVED, AN ATRIAL SEPTAL DEFECT (ASD) WAS OBSERVED WHICH WAS TREATED WITH A SEPTAL OCCLUDER. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THERE WERE NO ISSUES NOTED DURING THE PROCEDURE. TWO CLIPS WERE IMPLANTED, REDUCING THE MR TO 1+. AFTER THE STEERABLE GUIDING CATHETER (SGC) WAS REMOVED AND THE PATIENT WAS BEING WEANED OFF OF THE VENTILATOR, THE OXYGEN SATURATION STARTED TO DROP AND A RIGHT TO LEFT SHUNT WAS OBSERVED THROUGH THE ATRIAL SEPTAL DEFECT (ASD). A 20 MM SEPTAL OCCLUDER WAS USED TO CLOSE THE ASD AND THE VENTILATOR WAS REMOVED WITHOUT ISSUE. AFTER THE ASD WAS CLOSED, THE PATIENT WAS CONFIRMED TO BE STABLE. IT IS THE PHYSICIAN OPINION THAT THE ISSUE WAS NOT DUE TO THE MITRACLIP DEVICE, BUT THAT THE BLOOD WAS FLOWING BOTH WAYS THROUGH THE SEPTAL PUNCTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Perforation

  MAUDE report 6268756 ↗
• MalfunctionJan 9, 2017Leak/Splash

  THIS IS FILED TO REPORT THE LEAK IN THE STEERABLE GUIDING CATHETER (SGC), FOUND DURING DEVICE PREPARATION, WHICH, IF USED, HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING PREPARATION OF THE SGC, AFTER SUBMERGING THE TIP IN THE BASIN, THE SGC FAILED TO HOLD COLUMN. THREE TO FOUR (3-4) ATTEMPTS WERE MADE, BUT WERE UNSUCCESSFUL. THE DEVICE WAS NOT USED IN THE ANATOMY AND WAS REPLACED WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6234289 ↗
• MalfunctionDec 9, 2016Leak/Splash

  THIS IS FILED TO REPORT THAT THE DEVICE DID NOT HOLD FLUID COLUMN, AND IF WERE TO REOCCUR DURING USE, HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING PREPARATION OF THE STEERABLE GUIDING CATHETER (SGC), THE DILATOR WAS HYDRATED AND INSERTED INTO THE HEMOSTATIC VALVE, BUT WOULD NOT HOLD COLUMN. THE DEVICE WAS NOT USED IN THE ANATOMY AND WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6159621 ↗
• MalfunctionNov 22, 2016Device Contamination with Chemical or Other Material

  THIS IS FILED TO REPORT THE FOREIGN MATERIAL ON THE STEERABLE GUIDING CATHETER (SGC), WHICH IF USED, HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT AFTER THE SGC WAS UN-PACKAGED, A HAIR WAS NOTED ON THE DEVICE. THE DEVICE WAS NOT USED IN THE ANATOMY, AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6123087 ↗
• DeathNov 21, 2016Adverse Event Without Identified Device or Use Problem

  THIS IS CONSERVATIVELY FILED FOR THE PERICARDIAL EFFUSION AND PATIENT DEATH. IT WAS REPORTED THAT THERE WAS DIFFICULTY PERFORMING THE TRANSSEPTAL PUNCTURE. FINDING THE TENTING AND OBTAINING THE APPROPRIATE HEIGHT WAS A CHALLENGE. THE SEPTUM WAS PUNCTURED TWICE. ONE MITRACLIP WAS DEPLOYED WITHOUT ISSUE REDUCING MITRAL REGURGITATION (MR) FROM GRADE 4 TO TRACE. AT THE END OF THE PROCEDURE, AFTER ALL, THE DEVICES WERE REMOVED, A PERICARDIAL EFFUSION WAS NOTED AND SUSPECTED TO HAVE OCCURRED DURING THE DIFFICULT TRANSSEPTAL PUNCTURE. THE EFFUSION CONTINUED TO GROW AND THE PATIENT WENT INTO CARDIAC ARREST. CHEST COMPRESSIONS AND RESUSCITATION EFFORTS WERE SUCCESSFUL AND THE PATIENT WAS STABILIZED. THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND APPEARED TO BE DOING OKAY AS SHE WAS ABLE TO SIT IN A CHAIR, BUT EXPIRED TWO DAYS AFTER THE CLIP PROCEDURE. THE PHYSICIAN DID NOT THINK THE MITRACLIP CAUSED OR CONTRIBUTED TO THE PERICARDIAL EFFUSION OR THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death; Pericardial Effusion

  MAUDE report 6119104 ↗
• MalfunctionNov 7, 2016Loose or Intermittent Connection

  THIS IS FILED TO REPORT THE STOPCOCK CONNECTION WHICH, IF THE DEVICE WAS USED, HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING PREPARATION OF THE STEERABLE GUIDING CATHETER (SGC), THE STOPCOCK WAS ATTACHED TO THE FLUSH PORT OF THE SGC, BUT WOULD COME UNDONE. THREE DIFFERENT STOPCOCKS WERE ATTEMPTED, BUT ALL WOULD NOT STAY CONNECTED. THE SGC WAS NOT USED IN THE ANATOMY AND WAS REPLACED. A NEW SGC WAS USED WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6082914 ↗
• MalfunctionOct 21, 2016Loose or Intermittent Connection

  THIS IS FILED TO REPORT THAT DURING PREPARATION, THE STOPCOCK CONNECTION TO THE STEERABLE GUIDING CATHETER (SGC) HEMOSTASIS VALVE AND TO THE DILATOR WOULD NOT STAY SECURE, WHICH IF USED, HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT DURING PREPARATION OF THE STEERABLE GUIDING CATHETER (SGC 60721U135), THE STOPCOCK WAS CONNECTED TO THE SGC HEMOSTASIS VALVE, BUT WOULD UNSPIN. FIVE STOPCOCKS WERE ATTEMPTED, BUT THE SAME THING OCCURRED WITH ALL OF THE DEVICES. THE SGC WAS NOT USED IN THE ANATOMY, AND WAS REPLACED. THE NEW SGC WAS USED WITH ONE OF THE PREVIOUSLY ATTEMPTED STOPCOCKS SUCCESSFULLY. NEXT, ONE OF THE PREVIOUS STOPCOCKS WERE CONNECTED TO THE DILATOR FLUSH PORT FROM THE FIRST SGC PACK (60721U135), BUT THE STOPCOCK WOULD UNSPIN. THE DILATOR WAS NOT USED AND WAS REPLACED WITH THE DILATOR FROM THE NEW SGC. THE NEW DILATOR WAS USED SUCCESSFULLY WITH THE PREVIOUSLY ATTEMPTED STOPCOCK. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6049450 ↗
• MalfunctionOct 17, 2016Difficult to Insert; Torn Material

  THIS EVENT IS FILED FOR A TEAR IN THE SILICONE VALVE WITHIN THE HEMOSTASIS VALVE, WHICH HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MITRACLIP PROCEDURE ON (B)(6) 2016, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) OF GRADE 4. THE STEERABLE GUIDE CATHETER (SGC) AND CLIP DELIVERY SYSTEM (CDS) WERE PREPARED FOR USE PER INSTRUCTIONS FOR USE. THE CLIP INTRODUCER OF THE CDS COULD NOT PASS THROUGH THE HEMOSTASIS VALVE OF THE SGC AND THE CDS WAS SET ASIDE. THE SGC WAS REPLACED WITH A NEW SGC. THE SAME CDS WAS USED WITH THE NEW SGC AND NO ISSUES WERE NOTED. THE CLIP WAS DEPLOYED AND THE MR WAS REDUCED TO GRADE 1. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS BEING REPORTED BASED ON RETURNED DEVICE ANALYSIS WHICH REVEALED THAT THE SILICONE VALVE WAS TORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6034829 ↗
• MalfunctionSep 12, 2016Mechanical Problem; Torn Material

  THIS IS FILED BASED ON RETURNED DEVICE ANALYSIS WHICH FOUND THAT THE STEERABLE GUIDING CATHETER (SGC) SOFT TIP WAS TORN, WHICH HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE STEERABLE GUIDING CATHETER (SGC) WAS ADVANCED WITHOUT ISSUE. WHILE IN THE LEFT ATRIUM, THE +/- KNOB WAS TURNED APPROXIMATELY 60 DEGREES IN THE + DIRECTION, BUT THE TIP DID NOT RESPOND. THE SGC WAS REMOVED WITHOUT ISSUE, AND REPLACED. ONE CLIP WAS IMPLANTED, REDUCING THE MR TO 1. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE SGC SOFT TIP WAS TORN. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE DELIVERY SYSTEM FROM THE SGC AND THE CLIP DID NOT GET CAUGHT ON THE SGC TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5943244 ↗